Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 2006567f-4e41-487b-81d7-77b52b51fc4c
Route
TOPICAL
Published
Effective Date 2010-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.5 g)
Inactive Ingredients
Camphor (synthetic) Carbomer Homopolymer Type C Glycerin Isopropyl Alcohol Methylparaben Polysorbate 60 Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-06-17
Description

Menthol 2.5%

Purpose

Topical analgesic

Medication Information

Warnings and Precautions

For external use only

Purpose

Topical analgesic

Description

Menthol 2.5%

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Contact Us

[email protected] or call 877 677 3937

Directions
  • adults and children 12 years of age and older:  apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age:  ask a doctor

Do Not Use
  • on wound s or damaged skin

  • with a heating pad

  • on a child under 12 years of age with arthritis-like conditions

Package Label

Active Ingredient

Menthol 2.5%

Other Information
  • store at 20 ° to 25 ° C (68 ° to 77 ° F)
Inactive Ingredients

camphor, carbomer 940, glycerin, isoprophyl alcohol, methylparaben, polysorbate 60, purified water, and trolamine

When Using This Product
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Ask A Doctor Before Use If You Have

redness over the affected area.

Structured Label Content

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings and Precautions (34071-1)

For external use only

Purpose

Topical analgesic

Contact Us

[email protected] or call 877 677 3937

Directions
  • adults and children 12 years of age and older:  apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age:  ask a doctor

Do Not Use (Do not use)
  • on wound s or damaged skin

  • with a heating pad

  • on a child under 12 years of age with arthritis-like conditions

Package Label (Package label)

Active Ingredient (Active ingredient)

Menthol 2.5%

Other Information (Other information)
  • store at 20 ° to 25 ° C (68 ° to 77 ° F)
Inactive Ingredients (Inactive ingredients)

camphor, carbomer 940, glycerin, isoprophyl alcohol, methylparaben, polysorbate 60, purified water, and trolamine

When Using This Product (When using this product)
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

redness over the affected area.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:40.579167 · Updated: 2026-03-14T22:53:33.698024